A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

In plain English

What this trial is testing

This study is testing Duvakitug (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 16 to 80
• Any sex

Some of the main requirements, copied from the record:

• Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
• Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
• OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 751 participants are expected to take part.
• The study has 4 groups.
• Start date: 2026-01-16.
• Main results expected around 2028-09-21 (estimate from the record).
• 171 study sites listed (171 marked recruiting) in Argentina, Australia, Austria, Belgium and Bulgaria and 26 more countries.

Groups in this study

• Duvakitug - dose 1 (listed as: experimental group)
• Duvakitug - dose 2 (listed as: experimental group)
• Duvakitug - dose 3 (listed as: experimental group)
• Placebo (listed as: placebo group)

Main thing being measured

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). (Week 40)

In the researchers’ words

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.